Volume 7.48 | Dec 11

Volume 7.48, December 11, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Transplanted Brain Cells Hold Promise for Parkinson’s Disease: Transplanted neural stem cells hold promise for reducing the destruction of dopaminergic cells that occurs in Parkinson’s disease and for replacing cells lost to the disease.

DNA Spray Offers Cystic Fibrosis Hope: British researchers are to trial a new gene therapy for cystic fibrosis in which sufferers simply inhale a spray laden with DNA.


Parkinson’s Approach With Stem Cells A Promising First Step
Brain cells derived from human embryonic stem cells improved the condition of rats with Parkinson’s-like symptoms dramatically, but the treatment caused a significant problem – the appearance of brain tumors – that scientists are now working to solve.

HIV Gene Therapy ‘Ferry’ in Works
Scientists in New York are working to transform HIV into a gene therapy vector so that corrective DNA can be incorporated into patients’ chromosomes to help treat diseases such as thalassemia and sickle cell disease.

Molecular ‘Marker’ on Stem Cells Aids Research, Perhaps Therapies
A sugar molecule present on embryonic stem cells also has been found on the surface of a type of adult stem cell, a discovery that may help researchers isolate and purify adult stem cells for use in therapies aimed at bone healing, tendon repair and cartilage regeneration, researchers at UT Southwestern Medical Center report.

Apollo Life Science’s Human Proteins Lead to Improved Cancer Treatment by Boosting Stem Cell Growth
Initial studies show human proteins outperform competitor proteins in stimulating faster growth in numbers of blood-producing stem cells

siRNAs Can Slow Spread of Prion-based BSE, CJD
German scientists used special RNAs to halt the production of proteins loosened by prion disease similar to BSE and its human version, Creutzfeldt-Jakob disease, a new study says.

ReNeuron Announces Filing IND Application to the FDA for ReN001
ReNeuron Group plc today announces the filing of its first Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to commence initial clinical studies in the US with ReN001, its stem cell therapy for stroke.

Provenge(R), Activated Cellular Immunotherapy, Shows Promise for Treatment of Androgen Independent Prostate Cancer
Researchers involved in a multicenter trial have reported that Provenge(R) (Sipuleucel-T) may improve the survival of patients with asymptomatic metastatic androgen independent prostate cancer (AIPC) when compared to patients receiving a placebo.

Oxford BioMedica’s Trovax(R) Receives Positive Recommendation
Oxford BioMedica, a leading gene therapy company, has announced that it has received positive opinion from the Committee for Orphan Medicinal Products (COMP) recommending orphan drug designation for TroVax for the treatment of patients with renal cancer in the European Union (EU).

Stem Cell Therapy Moves from Theory to Reality
Despite setbacks and controversy, promising research is underway.

Experts Propose New Convention for Human Embryonic Stem Cell Derivation
Experts have today proposed a new convention for the reporting on the derivation of human embryonic stem cell (hESC) lines.


Proposal for a Universal Minimum Information Convention for the Reporting on the Derivation of Human Embryonic Stem Cell Lines
The implementation of novel methodology across the human embryonic stem cell (hESC) field is fraught with difficulties, not least of which is the highly variable reporting of the number and quality of embryos used to derive each new hESC line. In this editorial, the authors highlight the variation in data published and voice suggestions as to how the reporting can become standardized and so facilitate progress in human embryonic stem cell derivation.


Australian Parliament Lifts Cloning Ban
Lawmakers rejected the moral views of their political leaders Wednesday and lifted a four-year ban on cloning human embryos for stem cell research legislation that could put Australia at the forefront of research into diseases such as diabetes and Alzheimer’s.

California Stem Cell Board Approves Terms for Grants to For-profit Research Entities
The groundbreaking policy guarantees that the State of California will realize a tiered-return on CIRM stem cell research grants to for-profit entities whenever a commercial, CIRM-funded project generates $500,000 in revenue.

California Stem Cell Grants Could Focus on Single Disease
An assessment two years after California’s $3 billion initiative for embryonic stem cell research was approved by voters shows none of the expected breakthroughs in sight. A draft of an agenda for the state research institute created by the initiative sets as its top goal to establish that a therapy developed from human embryonic stem cells can “restore function for at least one disease” within the initiative’s 10-year life span.

Chief of California Stem Cell Venture Resigns
The president of the California Institute for Regenerative Medicine resigned his post today, citing “almost entirely personal reasons” for leaving the controversial $3-billion stem-cell research venture created in 2004 by the passage of Proposition 71.

New Jersey Lawmakers Agree on Stem Cell Funding Plan
New Jersey lawmakers said they have reached agreement on a $500 million plan to finance stem-cell studies, almost three years after the state became the second in the U.S. to legalize the research.


Mesoblast Television Coverage
Australian adult stem cell company, Mesoblast Limited, has confirmed that a recent news item broadcast focused on its adult stem cell platform technology.

Stem Cell Firm on Growth Fast-track
Stem cell specialist NovaThera is pursuing a strategy of ‘organic growth,’ with plans to double its Cambridge workforce, build a new manufacturing plant and raise a sizable venture capital round.

Immunicon Launches EasyCount(TM) System for Automated Cell Counting
Immunicon Corporation today announced the availability of the EasyCount(TM) System, a fluorescent microscopy-based imaging system that accurately counts dead and live nucleated cells and automatically calculates cell viability, in a single test.

StemCells, Inc. Announces Key Executive Appointments
Dr. Stephen Huhn joins StemCells Inc. as head of neural program; Ann Tsukamoto, Ph.D., is appointed Chief Operating Officer; and Maria Millan and Rodney Young are promoted.


NIH Policy on Late Submission of Grant Applications – Clarification for Multiple PI Applications and New Submission/Receipt Dates

Shared Instrumentation Grant Program (S10)


Public Hearing: Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management

Approved Biological NDA and ANDA Applications

Current Licensed Establishments and Products – Update

All new CBER information can be reached from the What’s New page at What’s New Page



Senate Confirms Von Eschenbach as Chief of FDA
Andrew von Eschenbach gained the overwhelming support of the Senate in his long-delayed bid to become chief of the FDA. Senators supported his nomination by a vote of 80 to 11.


Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
Submission deadline: February 16, 2007

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

Robert Weinstein, MD
Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, MA.

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